BRAN Pilot Study: Metabolic Signature of Wheat Bran Related to Gut Fermentation in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Nutritional Intervention

• Registration Number: NCT03717311
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in 13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then a following will be realized on 24h with breath, urine, fecal and blood samples. Analysis will be performed on these samples in order to determine potential biomarkers of fibers consumption to evaluate the metabolic effects of this consumption and to refine the relevance of nutritional recommendation regarding fibers for healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Study Start: 2018-11-08
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Subject able to understand the information given to him and having signed the informed consent form.
• subject having had a medical examination during the selection visit
• Healthy subject
• Female gender
• Age between 20 and 40 years (limits included)
• No Smoking
• Body mass index between 20 and 25 kg / m2 (limits included).
• fiber consumer ≥ 18 g / day
• Do not present any food allergy, nor food intolerance to the products of the study.
• Having no particular diet (vegetarian, vegan, high protein, etc.)
• Having a stool frequency ranging from 1 to 2 per day over the last 2 months
• Absence of pathology detectable by clinical examination and medical examination that may interfere with the evaluation criteria of the study.
• Sedentary subject or practicing steady regular physical activity during the entire study (maximum 4 hours per week).
• Accepting to submit to the protocol of the study with a day of hospitalization of 24h
• Stable weight in the last 3 months (+/- 5% of total body weight)
• Affiliation to a social security scheme.

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Exclusion Criteria

General criteria

• Subject presenting unstable medical or psychological conditions which, according to the investigator, could lead the subject to be non-compliant or uncooperative during the study or could compromise the safety or participation of the subject under study (according to Articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code).
• Failure to respect the exclusion period of another study specified in the "National Volunteer File".
• Major subject under guardianship.
• Private subject of his liberty by judicial or administrative decision.
• Subject having exceeded the annual amount of compensation for participation in research protocols.
• Not having a refrigerator and / or freezer (necessary for the conservation of collections of urine and / or stool made at home) Biological criteria
• Total blood cholesterol> 11 mmol / L or blood triglycerides> 3 mmol / L
• Fasting blood glucose> 7 mmol / L
• CRP> 10 mg / L
• Demonstration of a biological abnormality judged by the investigator to be clinically significant
• Transaminases (ASAT and ALAT) and gamma GT greater than 1.5 times the upper limit of normal

Medical and therapeutic criteria:

• History of bariatric surgery
• History of digestive surgery with the exception of appendectomy
• Subject presenting gastrointestinal disorders such as ulcers, diverticula or inflammatory bowel diseases
• Diabetes type 1 or 2.
• Chronic renal failure.
• Chronic liver failure.
• known gastroparesis, gastrectomy, colectomy.
• History of chronic gastrointestinal disease with malabsorption.
• External pancreatic insufficiency.
• Known endocrine pathology that can interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, ...).
• Subject with organic intestinal disease.
• subject who has undergone antibiotic therapy in the 3 months preceding the study may interfere with transit or intestinal microbiota:
• Subject treated with a drug that may interfere with carbohydrate metabolism:
• Corticosteroids.
• anorectics.
• High dose gastric bandages.
• Subject having a concomitant pathology incompatible with the constraints of the protocol or which may interfere with the evaluation of the main criterion.
• PA systolic not between 100 and 140 mmHg and diastolic not between 50 and 90 mmHg
• Dieting or wishing to lose weight
• Pregnant woman or wishing to be pregnant or breastfeeding (interrogation data)
• Alcoholism or abuse or dependence on another proven drug. Consumption of more than 3 alcoholic beverages per day is considered abusive. An alcoholic beverage is 30 mL of spirits, 120 mL of wine or 330 mL of beer
• Donation of blood in the 2 months preceding the selection visit
• Subjects consuming dietary supplements
• Subjects refusing to follow the dietary instructions on the 3 days preceding the test day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
13C enriched bran biscuit	Nutritional Intervention	The volunteers will consume 5 biscuits (100g) enriched with 13C bran with a 200 ml hot beverage in 15 minutes

Primary Outcome Measures

Name	Time	Method
Measurement of the 13-C isotopic enrichment kinetics	24 hours	Measurement of the 13-C isotopic enrichment kinetics of plasmatic SCFAs after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 24h.The concentration and the 13C isotopic enrichment of SCFAs in the plasma will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon

Secondary Outcome Measures

Name	Time	Method
Gastro intestinal symptoms	one week	By questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).
measurement of plasmatic PUFA concentration	24 hours	Plasma samples will be prepared and analysed by gas-liquid chromatography-
Measurement of the 13-C isotopic enrichment kinetics in CO2 and CH4 from exhaled gases during 24h after fibers ingestion.	24 hours	Gases will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.
Measurement of H2 kinetics in the exhaled breath during 24h.	24 hours	H2 will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.
The appearance kinetic of 13C glucose in the plasma	24 hours	Plasma samples will be prepared and analysed by coupling gas chromatography-combustion-isotopic mass spectrometry according to the method used at the CRNH Rhône-Alpes (Sauvinet et al., 2009)
Sphingolipid molecular species concentrations in plasma and TGRL	Day 0	Isolation of plasma and triglyceride-rich lipoproteins (TGRL) fractions by ultracentrifugation and measurement by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)
apolipoprotein B48 concentrations in plasma and TGRL	Day 0	apolipoprotein B48 concentrations in plasma and TGRLby ELISA technique
TGRL particle sizes	Day 0	TGRL particle sizes by laser granulometry
Stool consistency	one week (at each stool)	Stool consistency by Bristol Stool Chart (type1-7)
Stool frequency	one week	By questionnaire
Measurement of the 13-C isotopic enrichment kinetics of SCFAs in urines after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 24h.	24 hours	The concentration and the 13C isotopic enrichment of SCFAs in the urine will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon
Measurement of the 13-C isotopic enrichment kinetics of SCFAs in feces after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 48h or 72h.	Hour 72	The concentration and the 13C isotopic enrichment of SCFAs in the urine will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon
The platelets aggregation as cardimetabolic risk marker in the plasma	Day -30	An immuno-enzymatic dosage of platelet thromboxan B2, after the chylomicrons (CM) incubation with platelets, will be done. The measurement of platelet aggregation by aggregometry will be done after the CM and collagen stimulated platelet incubation.
Fatty acids in lipid classes (triglycerides, phospholipids, cholesteryl esters) of plasma and TGRL	Day 0	Determination of molar percentages of fatty acids in lipid classes (triglycerides, phospholipids, cholesteryl esters) of plasma and TGRL, following analysis by gas chromatography.
Intensity of gastro-intestinal symptoms thanks to an analogue visual scale (AVS)	24 hours	This AVS allows the measurement of 8 gastro-intestinal symptoms intensity, often described after fibers consumption on a 100 mm scale.
Metagnomic of gut microbiota	one week (at each stool)	Stool samples will be prepared and analysed by 16SrDBA ilimina sequencing

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes; 🇫🇷 Pierre-Bénite, France